FDA warns Chinas Shanghai Institute of Pharmaceutical Industry that the agency may withhold approval of ANDAs or supplements listing it as a manufactu...
Four pharmaceutical stakeholders suggest edits to the FDA BEST glossary of biomarker, endpoints, and other tools.
AstraZeneca says it will work closely with FDA on next steps after receiving a complete response letter for its PT010 experimental COPD drug.
Federal Register notice: FDA announces the fee rate of $2,167,116 for using a tropical disease priority review voucher for fiscal year 2020.
Federal Register notice: FDA makes available a draft guidance for industry #261 entitled Eligibility Criteria for Expanded Conditional Approval of New...
FDA and the U.S. Drug Enforcement Administration issue joint Warning Letters to four online networks that were illegally marketing unapproved and misb...
FDA clears a CivaTech Oncology 510(k) for its CivaDerm, a radiation therapy bandage designed for intraoperative or surface radiation to treat skin can...
FDA posts an 11-item Form FDA-483 to U.S. Specialty Formulations after concluding an inspection of its Bethlehem, PA manufacturing facility.